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TRANSCRIPT
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匀礀渀攀爀最礀 伀爀愀渀最攀 倀愀瀀攀爀 ⼀ ㈀ ㈀ 匀瀀爀椀渀最 ⼀ 儀甀愀爀琀攀爀
꤀ 匀礀渀攀爀最礀 刀攀猀攀愀爀挀栀 䜀爀漀甀瀀 眀眀眀⸀猀爀最挀爀漀⸀挀漀洀
刀攀猀攀愀爀挀栀 爀攀瀀漀爀琀
䌀氀椀渀椀挀愀氀 琀爀椀愀氀猀椀渀 刀甀猀猀椀愀
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Synergy orange paper
ForewordThe Orange Paper is a free publication produced
by Synergy Research Group for the
pharmaceutical industry since 2007. It pulls
together data from numerous public sources
into a single brief document to aid decision
makers planning to conduct clinical trials. It is
produced quarterly, with an annual summary at
the close of each year.
All of the data within this document are actual
on date: 02 /04 /2020
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Synergy orange paper
Table of ContentsExecutive Summary
Clinical Trials in Russia in Q1 2020
Trial Data
Absolute numbers and per cent change of trials by
type, phase and therapy area
Sponsor Data
Absolute numbers and per cent change in number
of studies, breakdown by study type, phase and
therapy area
Subject Data
Absolute numbers and per cent change in number
of subjects, breakdown by study type, phase and
therapy area
Research Site Data
Top performing sites, breakdown into BE &
Phase I, Phase II-III and Phase IV
CRO Data
Top 10 CROs by absolute number of new studies
Regulatory Data
New drugs approved by FDA and EMA with
Russian sites, update on Regulatory changes
and CTA timelines
Inspection Data
About Synergy
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Synergy orange paper
Executive SummaryDuring Q1 2020 the Ministry of Health of the Russian
Federation approved the start of 145 new clinical trials
of all types, with an overall year on year decline of 5%
by total number of studies.
The dominant type of clinical trials conducted in
Russian sites in Q1 2020 were MMCT (Multinational
Multi-center Clinical Trials) with 46% market share. The
most prevalent Phase of clinical trials conducted in
Russian sites by total number of studies was Phase III.
The top-10 International Sponsors account for 45% of
the total number of studies conducted in Russia, and
for 34% of all subjects enrolled during the year. The
top-10 Russian sponsors take up approximately 15% of
the market by total number of trials conducted in
Russia and have 31% of all subjects enrolled in these
trials.
The twenty largest pharmaceutical companies
combined account for 60% of all clinical trials
conducted in Russia and for 65% of all subjects
enrolled.
During Q1 2020 the Center for Drug Evaluation and
Research (CDER) of the U.S. FDA approved 29 new
drugs, including 8 new molecular entities (NME);
other approvals concerned new dosages,
combinations or manufacturers. Seven of these 29
drugs were tested (or being studied) in clinical trials
involving Russian sites.
In Q1 2020 the Committee for Medicinal Products
for Human Use (CHMP) of the European Medicine
Agency (EMA) approved 23 new drugs. Nine of
these drugs were tested (or being studied) in
clinical trials involving Russian sites.
The top-5 domestic pharmaceutical
manufacturers in Russia during Q1 2020
were: Microgen, PSK Pharma, Polysan, FZ
Immunoleks and SmartBioTech.
The top-5 International Sponsors in Russia
during Q1 2020 were: Merck, Eli Lilly, Sanofi,
Hoffmann-La-Roche and Pfizer.
According to the U.S. FDA data, there were
no FDA inspections conducted in Russian
investigative sites during Q1 2020.
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Synergy orange paper
Trial DataDuring Q1 2020 the Ministry of Health of the Russian
Federation approved the start of 145 new clinical trials of all
types, including local and bioequivalence studies. This
represents a 5% year on year decline by the total number of
studies.
The dominant type of clinical trials conducted across
Russian sites in Q1 2020 were MMCT (Multinational
Multi-center Clinical Trials). The market share of MMCTs
increased from 39% to 46% of the total number of trials. The
market share of Local Clinical Trials (LCTs) crashed more
than twicely from 31% to 14% whilst the Bio-equivalent (BE’)
share raised from 29% to 39%.
153 145
Total
60 67
MMCT
40
21
4557
LCT BE
Q1 2019 Q1 2020
Breakdown of Clinical Trials in Q1 2020 by Type
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Trial DataThe most prevalent Phase of clinical trials conducted in
Russian sites by total number of studies was Phase III.
The total number of Phase III trials dropped slightly by 5% –
from 66 trials in Q1 2019 to 63 trials in Q1 2020.
104
23 20
66 63
91
Phase I Phase II Phase III Phase IV
Q1 2019 Q1 2020
Breakdown of Clinical Trials by Phase
Percentage Breakdown of Clinical Trials by Type
LCTMMCT BE
0
10
20
30
40
50
60
70
80
90
100
% Q1 2019
39%
31%
29%
Q1 2020
46%
14%
39%
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Trial DataThe largest number of clinical trials initiated in Russia
during Q1 2020 were related to Oncology (24 studies),
Neurology (10 studies) and Gastroenterology (9 studies).
Other dominant therapy areas include Hematology,
Rheumatology and Endocrinology.
More than one therapeutic area may be assigned to a
trial. BE studies were not included in any therapeutic
area group.
Breakdown
of Clinical Trials
in Russia during Q1 2020
by Therapeutic Area
Oncology
Neurology
Gastroenterology
Hematology
Rheumatology
Endocrinology
Dermatology
Infectious diseases
Other areas
27%
11%
10%
9%
8%
7%
6%
5%
9%
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Sponsor DataClinical trials initiated in Russia during Q1 2020 were sponsored by
pharmaceutical companies from Russia and 22 foreign countries.
The combined market share of international pharmaceutical
companies involved in the Russian Clinical trials market raised from
56% to 64% of all studies.
6885
52
93
Q1 2019 Q1 2020
Russian Sponsors
International Sponsors
Breakdown of Clinical Trials by Sponsor Origin
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0
10
20
30
40
50
60
70
80
90
100
% Q1 2019
44%
56%
Q1 2020
36%
64%
Russian Sponsors International Sponsors
Percentage Breakdown of Trials by Sponsor Origin
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3 1 3
1710
53
0 1
Phase I Phase II Phase III Phase IV
Russian Sponsors
International Sponsors
Breakdown of Clinical Trials by Sponsor’s Origin and Phase
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Sponsor DataThe most prevalent Sponsor’s countries of origin in Q1 2020 were
Russia (52 studies), U.S. (32 studies) and Switzerland (10 studies).
Other prominent countries include Sweden (6 studies), Germany
(5 studies) and France (5 studies).
The dominant Phase of Clinical trials conducted across Russian
sites by international pharmaceutical companies in the Q1 2020
was Phase III with 72% share among Phase I – IV studies.
Russia
U.S.
Switzerland
Sweden
Germany
France
Belgium
India
Rest of the World
36%
22%
7%
4%
3%
3%
3%
3%
17%
Sponsors' Country
of Origin for Q1 2020
(as % of all Studies)
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Synergy orange paper
InternationalSponsor Ranking
Combined market share of these companies
№
1
2
3
4
5
6
7
8
9
10
Company Name
Merck
Eli Lilly
Sanofi
Hoffmann-La Roche
Pfizer
AstraZeneca
Bristol-Myers
Novartis
Jadran-Galenski
Camurus
No. studies
7
5
5
5
4
4
3
3
2
2
45%
No. subjects
480
1 098
297
229
217
200
155
111
268
69
34%
Top-10 International
Trial Sponsors
in Russia in Q1 2020
Combined market share shown as a percentage of both
international and Russian sponsors.
Observational Clinical trials and Clinical trials without FDA-defined
phases (from I to IV) were not counted in this ranking.
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RussianSponsor Ranking
Combined market share of these companies
№
1
2
3
4
5
6
7
8
9
10
Company Name
Microgen
PSK Pharma
Polysan
FZ Immunoleks
SmartBioTech
Obnovlenie
OTC Pharm
NIzhPharm
SPBNIIVS
Generium
No. studies
3
2
1
1
1
1
1
1
1
1
15%
No. subjects
980
52
432
414
300
220
140
130
125
44
31%
Top-10 Russian
Trial Sponsors
in Russia in Q1 2020
Combined market share shown as a percentage of both
international and Russian sponsors.
Bio-Equivalence (BE) studies were not included in this ranking.
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Subject DataThe overall number of subjects enrolled in clinical trials
initiated in Russia during Q1 2020 reached a total of 9,146
subjects – a 22% decline in comparison with Q1 2019, when
11,666 subjects were enrolled.
The most prevalent Phase of clinical trials by the number of
participating subjects was Phase III with 82% of all subjects
enrolled.
575 2201 552 1 361
8 3917 525
1 14840
Studies indicated by sponsors as Phase I-II in the
applications submitted to Ministry of Health, are
shown in Phase II studies group; Phase II-III – in
Phase III group, Phase III-IV –in Phase IV group.
Phase I Phase II Phase III Phase IV
Q1 2019 Q1 2020
Breakdown of Number of Subjects Enrolled by Phase
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Percentage Breakdown of Number of Subjects by Phase
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Combined market share of these sites
№
1
2
3
4
5
Site Name
Probiotec Medical Center
Clinical Hospital #2, Yaroslavl region
Ecosafety
No. studies
9
8
7
4
3
21%
City
Moscow Region
Yaroslavl
Saint-Petersburg
Moscow
Saint-Petersburg
Combined market share of these sites
№
1
2
3
4
5 Rostov State Medical University
First St.Petersburg State Medical University named after I.P. PavlovFirst Moscow State Medical Universitynamed after I.M. Sechenov
Russian Oncological Scientific Centernamed after N.N. BlokhinNational Medical ResearchCenter for Radiology
Center for Physical and Chemical Medicineof the Federal Medical and Biological Agency
Human Brain Institutenamed after N.P. Bekhtereva
City
Saint-Petersburg
Moscow
Moscow
Moscow
Rostov-on-Don
No. studies
13
12
10
9
7
35%
Top-5 Russian
Research Sites
(BE and Phase I
Studies)
Top-5 Russian
Research Sites
(Phase II-IV Studies)
ResearchSite Data
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ResearchSite Data
Combined market share of these sites
№
1
2
3
4
5
6
7
8
9
10
Site Name
Clinical Hospital #2, Yaroslavl region
Rostov State Medical University
City Clinical Hospital #40
Ecosafety
First St.Petersburg State Medical Universitynamed after I.P. Pavlov
First Moscow State Medical Universitynamed after I.M. SechenovRussian Oncological Scientific Centernamed after N.N. Blokhin
National Medical ResearchCenter for Radiology
St. Petersburg Clinical Scientific and PracticalCenter for Specialized Types of Medical Care
Human Brain Institutenamed after N.P. Bekhtereva
City
Yaroslavl
Saint-Petersburg
Moscow
Moscow
Moscow
Saint-Petersburg
Saint-Petersburg
Rostov-on-Don
Saint-Petersburg
Saint-Petersburg
No. studies
14
13
12
11
9
8
8
7
7
6
66%
Top-10 Russian
Research Sites
(all Studies)
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CRO Data CRO Rankings for Q1 2020 in Russia(Phase I - IV studies)№
1
2
3
4
5
6
7
8
9
10
*Combined market share based on total studies conducted both
sponsors and CROs.
Observational Clinical trials and Clinical trials without FDA-defined
phases (from I to IV) were not counted in this ranking.
Company Name
PPD
IQVIA
Syneos Health
ICON
Clinical Trials and Development
iPharma
OST Rus
PSI
Parexel
Pharmaceutical ResearchAssociates CIS
No. studies
5
4
3
2
2
1
1
1
1
1
24%
No. subjects
286
111
110
245
69
432
264
70
70
68
19%Combined market share of these companies*
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CRO Data CRO Rankings for Q1 2020 in Russia(BE studies)№
1
2
3
4
5
6
7
8
9
10
*Combined market share based on total studies conducted
both sponsors and CROs.
Only BE (bioequivalence) studies were included in this ranking.
Company Name
ClinPharmDevelopment
Biomapas
X7 Clinical Research
ARS
OST Rus
ClinPharmInvest
Chorich Pharm
Probiotec Medical Center
IMTEC
Global Pharma
No. studies
4
4
2
2
1
1
1
1
1
1
32%
No. subjects
341
144
130
64
110
80
70
60
50
44
36%Combined market share of these companies*
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Synergy orange paper
Regulatory Data
During Q1 2020 the Center for Drug Evaluation and Research (CDER) of the
U.S. FDA approved 29 new drugs; 8 of them were new molecular entities
(NME); other approvals concerned new dosages, combinations or
manufacturers. Seven of these 29 drugs were (or are being) studied in
clinical trials involving Russian sites.
In Q1 2020 the Committee for Medicinal Products for Human Use (CHMP)
of the European Medicine Agency (EMA) approved 23 new drugs, including
4 generics, 2 biosimilar and 1 orphan medicines. Nine of these 23 drugs
were (or are being) studied in clinical trials involved Russian sites.
Source: FDA
№
1
2
3
4
5
6
7
Appr. date
16 / 01 / 2020
16 / 01 / 2020
27 / 01 / 2020
21 / 02 / 2020
02 / 03 / 2020
04 / 03 / 2020
25 / 03 / 2020
Drug (active ingredient)
Monoferricnda (Ferric Derisomaltose)
Rybelsusnda (Semaglutide)
Nexletolnda (Bempedoic Acid)
Sarclisabla (Isatuximab-IRFC)
Durystanda (Bimatoprost)
Zeposianda (Ozanimod Hydrochloride)
Trijardy (Empagliflozin; Linagliptin;Metformin Hydrochloride)
Company
PharmaCosmos
Novo Nordisk
Boehringer Ingelheim
Esperion Theraps
Sanofi
Allergan
Celgene
Drugs studied at Russian sitesand approved by FDA in Q1 2020
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Synergy orange paper
Inspection Data
FDA Inspections
According to the U.S. FDA data, there was no FDA
inspections conducted in a Russian investigative site
during Q1 2020.
Roszdravnadzor Inspections
According to the Roszdravnadzor quarterly report, as
of 04/02/2020 there were no Regulatory inspections
conducted by Roszdravnadzor during Q1 2020.
Source: EMA
№
1
2
3
4
5
6
7
8
9
Appr. date
31/01/2020
31/01/2020
31/01/2020
31/01/2020
27/02/2020
26/03/2020
26/03/2020
26/03/2020
26/03/2020
Drug (active ingredient)
Ruxience (Rituximab)
Liumjev (Insulin Lispro)
Rybelsus (Semaglutide)
Fetcroja (Cefiderocol Sulfate Tosilate)
Zeposia (Ozanimod Hydrochloride)
Sarclisa (Isatuximab)
Budesonide / Formoterol (BudesonideFormoterol Fumarate Dihydrate)
Atectura Breezhaler (Indacaterol Acetate; Mometasone Furoate)
Bemrist Breezhaler (IndacaterolAcetate; Mometasone Furoate)
Company
Pfizer
Teva
Eli Lilly
Novo Nordisk
Shionogi
Novartis
Novartis
Celgene
Sanofi
Drugs studied at
Russian sites
and approved by
EMA in Q1 2020
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Synergy orange paper
About SynergySynergy Research Group is a contract research organization
successfully operating in Russia, Kazakhstan, Ukraine and Canada
since 2002.
From year to year our company is consistently in the TOP-10 of
market leaders by the numbers of conducted clinical studies and
enrolled patients.
The high recruitment rates of the emerging markets combined
with innovative technology allows Synergy to conduct faster,
more cost-effective studies without sacrificing quality for our
clients.
We ensure the highest level of quality of SOPs and of final study
data for all clinical studies conducted by our company. We’re
continuously working on improvements of our SOPs, study risk
management and IT infrastructure – replacing outdated R&D
strategies by novel, more efficient approaches to clinical research.
ForewordTable of ContentsExecutive SummaryTrial DataSponsor DataSubject DataResearch Site DataCRO DataRegulatory DataInspection DataAbout Synergy